西藥製劑廠使用自用原料之現況調查(III)

近年來關於生產藥品的原料（原料藥）安全事件層出不窮，尤以中國大陸輸出「假甘油」及「抗凝血劑Heparin」導致藥品品質重大危害事件，最受注目，又因近年來偽劣藥品的猖獗，行政院為杜絕偽劣假藥源頭、打擊不法，於99年9月20日「加強取締偽劣假藥及非法廣播電台」專案第25次會議決議，針對西藥製劑廠進口的自用原料加強實地查核，了解我國西藥製劑廠使用自用原料之現況，以防止自用原料流入不法之用途。本署自99年11月起，連續3年查核進口自用原料之流向及使用情形。發現不符合情形已逐年下降，由99年71家(64%)降到101年18家(15%)，顯示在本署以及地方衛生局共同的努力下，業者對於自用原料的使用已有明顯改善。現階段以健全自用原料申請與使用之回饋機制，並配合公告之PIC/S GMP國際標準、推動原料藥GMP之執行等措施，強化自用原料管理，以保障民眾用藥安全。

關鍵字

自用原料；西藥製劑廠

並列摘要

In recent years, the safety incidents from raw materials (APIs) made for producing drug products are increasing. Among these, the incidents of ＂fake glycerin＂ and ＂Heparin＂ made in China had caused significant concern. In view of the rampant situation of counterfeit and inferior drugs, the Executive Yuan convened the 25^(th) session of ＂Strength on cracking down the counterfeit/inferior drugs and illegal radio stations＂ on September 29th, 2010 and passed a resolution of ＂Block Source and Ban Illegality＂. In which inspection on raw materials used by modern pharmaceutical manufacturers will be reinforced to prevent the raw materials from being used illegally. Since November 2010, the inspections of raw materials used by modern pharmaceutical manufacturers were conducted by TFDA. After consecutive inspections for 3 years, the happening of deficiency has decreased. In 2010, there were 71 pharmaceutical manufactures found to violate Pharmaceutical Affairs Law. In 2012, the number of violations was down to 18. It shows under the joint effort of TFDA and the local health bureaus, the usage of raw materials by modern pharmaceutical manufacturers has improved significantly. It indicated that raw materials should be managed with more attention, at the present stage, by developing a feedback system on the application and usage of raw materials, reinforcing the management of agents, implementing the high standard PIC/S GMP, and implementing GMP on raw materials, to protect public safety of drug usage.

並列關鍵字

GMP ； raw materials ； modern pharmaceutical manufactures

國際替代計量

西藥製劑廠使用自用原料之現況調查(III)

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